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The goal of this pilot randomized controlled trial is to determine whether volume-oriented incentive spirometry-assisted diaphragmatic breathing exercise (VIS-assisted DBE) can improve reflux-related symptoms and health-related quality of life in adults with functional heartburn (FH) or reflux hypersensitivity (RH).
The main questions it aims to answer are:
Does VIS-assisted DBE reduce reflux-related symptoms compared with usual care? Does VIS-assisted DBE improve health-related quality of life compared with usual care? Researchers will compare VIS-assisted DBE plus usual care with usual care alone to determine whether the intervention provides additional benefits in symptom relief and quality of life.
Participants will:
Complete baseline clinical evaluations and symptom questionnaires. Be randomly assigned to either the VIS-assisted DBE group or the usual care group.
Receive either VIS-assisted diaphragmatic breathing exercises twice daily for 20 minutes over a 4-week period in addition to usual care, or usual care alone.
Complete follow-up assessments after the 4-week intervention, including symptom and quality-of-life questionnaires
Functional heartburn (FH) and reflux hypersensitivity (RH) are disorders of gut-brain interaction characterized by persistent reflux-related symptoms despite the absence of significant esophageal acid exposure or structural abnormalities. Although proton pump inhibitors are widely used for reflux-related disorders, many patients with FH and RH continue to experience persistent symptoms, resulting in reduced health-related quality of life. Current evidence suggests that altered esophageal sensory processing, autonomic nervous system dysfunction, and impaired gut-brain axis regulation contribute to symptom generation in these disorders.
Diaphragmatic breathing exercise has emerged as a promising non-pharmacological intervention that may improve diaphragmatic function, enhance vagal activity, and reduce reflux-related symptoms. Volume-oriented incentive spirometry (VIS) provides visual feedback during breathing training and may improve the consistency and effectiveness of diaphragmatic breathing. However, evidence regarding the therapeutic effects of VIS-assisted diaphragmatic breathing exercise in patients with FH or RH remains limited.
This prospective, parallel-group, pilot randomized controlled trial is designed to evaluate the clinical effectiveness of VIS-assisted diaphragmatic breathing exercise in adults with FH or RH. Participants will be randomly assigned to receive either VIS-assisted diaphragmatic breathing exercise in addition to usual care or usual care alone. The study will assess whether the intervention improves reflux-related symptoms and health-related quality of life compared with usual care.
The findings of this study are expected to provide preliminary evidence regarding the feasibility and potential clinical benefits of VIS-assisted diaphragmatic breathing exercise as an adjunctive non-pharmacological treatment for functional heartburn and reflux hypersensitivity, and to support the design of future larger randomized controlled trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise Group (VIS) | Experimental | Participants will perform diaphragmatic breathing exercises assisted by a volume-oriented incentive spirometer twice daily for 20 minutes per session over a 4-week intervention period under standardized instructions. |
|
| Usual Care | Active Comparator | Participants will receive standard pharmacological treatment and lifestyle modification education without structured diaphragmatic breathing exercise. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise | Behavioral | Participants will perform diaphragmatic breathing exercises assisted by a volume-oriented incentive spirometer twice daily for 20 minutes per session over a 4-week intervention period under standardized instructions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score | The primary outcome is the change in Gastroesophageal Reflux Disease Questionnaire (GERDQ) score from baseline to the end of the 4-week intervention. The GERDQ is a validated patient-reported questionnaire used to assess the frequency and severity of reflux-related symptoms. Higher scores indicate more severe symptoms. The change in GERDQ score will be compared between the intervention and usual care groups | From baseline to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Score | The secondary outcome is the change in the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) score from baseline to the end of the 4-week intervention. The GERD-HRQL questionnaire evaluates the impact of reflux-related symptoms on health-related quality of life. Higher scores indicate poorer health-related quality of life. The change in GERD-HRQL score will be compared between the intervention and usual care groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shu-Ju Tu, NP, PHD Candidate | Contact | +88647238595 | 7591 | 79610@cch.orh.tw |
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Participants will be randomized in a 1:1 ratio to one of two parallel study arms using block randomization.
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|
| standard pharmacological treatment with lifestyle modification education | Behavioral | Participants will receive standard pharmacological treatment and lifestyle modification education without structured diaphragmatic breathing exercise. |
|
| From baseline to Week 4 |
| Change in Reflux Disease Questionnaire (RDQ) Score | The secondary outcome is the change in the Reflux Disease Questionnaire (RDQ) score from baseline to the end of the 4-week intervention. The RDQ is a validated patient-reported questionnaire that assesses the frequency and severity of reflux-related symptoms. Higher scores indicate more severe symptoms. The change in RDQ score will be compared between the intervention and usual care groups. | From baseline to Week 4 |